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IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma
Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patientsTumor shrinkage observed in 31 of 35 (89%) Any-Line MUM patientsMedian PFS not yet reached and >5 months in evaluable First-Line MUM patients; observed median PFS of ~5 months in evaluable Any-Line MUM patientsHistorical % ORR and median PFS by other therapies in MUM have been low, ranging from ~0% to 5% ORR and ~2 to 3 months median PFSProof-of-concept for use in (neo)adjuvant UM with tumor shrinkage in 5 of 5 ocular lesions, including reductions of ~-74% and -67%, each with improved visual symptomsTotal UM and MUM annual incidence in US/EU28 projected at over 13,000 patients, and total UM and MUM prevalence in US/EU28 projected at over 110,000 patientsTargeting to initiate potential registrational trial for Daro + Crizo in First-Line MUM in Q1 2023 and company-sponsored trial for Daro monotherapy in (neo)adjuvant UM in Q4 2022Investor webcast and call scheduled for Monday, September 12, 2022, at 8:00am ETSOUTH SAN FRANCISCO, Calif., Sept. 11, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385).\n\n \n \n \n \n \n \n\n \n\"The confirmed partial responses and high percentage of patients with tumor shrinkage shown in these interim Phase 2 data are extremely encouraging for patients with metastatic uveal melanoma. The 50% overall response rate and greater than 5 months median progression free survival observed in first-line MUM patients reflects the potential for a compelling clinical efficacy profile irrespective of haplotype (HLA-A*02:01) status. The partial responses shown in first-line and any-line MUM patients are clinically significant and build on previously-reported results for any-line MUM patients, now with a larger patient data set,\" said Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health.\n\"The clinical efficacy observed in first-line patients in these interim Phase 2...